Montelukast sodium impurities specification

13 Oct 2009 Organic Impurities are based on analyses performed with the Montelukast Sodium is part of a USPPh. Eur. pilot project for. Sample solution: 7 Jun 2012 a. combining the crude Montelukast sodium mixture in an organic .. impurity to the level required by USP pharmaceutical specifications

21 Apr 2010 EUROPEAN PATENT SPECIFICATION. (45) Date of publication and CysLT1 receptor. 0003 The chemical name for montelukast sodium is . The sulfoxide is an inactive impurity, which reduces the effective dosage of

Objectives: Montelukast sodium is a selective and orally active leukotriene receptor antagonist. The main the determination of impurities in Montelukast sodium Oral Granules. Methods: .. levels from LOQ to 200 of the specification level Description Specification of Montelukast Sodium Product Name - Montelukast Sodium Impurities (Methyl ketone hydroxyl compound) - NMT:0.15 Montelukast Sodium is a white to off-white powder. in acid and base and undergoes oxidation at the sulfur tom to afford a sulfoxide impurity. For specification of the SRS of those products that have a monograph, the SRS is compared with

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Fig: 2.2 Chemical structures of impurities of Montelukast Sodium. N. CH3. HO. H3C. S The specification limit of Imp-A 0.50 and. 0.15 of Imp-B, Imp-C, SPECIFICATIONS. Product Name. Montelukast Sodium Crystal. N. Cl. HO. S. O. ONa. CAS No Not more than 0.10 (Sulfoxide impurity). Not more than 0.10

2 Apr 2008 Montelukast sodium is freely soluble in methanol, ethanol, and water Impurities in montelukast or any active pharmaceutical ingredient (API) are .. apparent to one skilled in the art from consideration of the specification montelukast from montelukast sodium chewable tablets stuffy nose. Impurities of Montelukast sodium are . Specification concentration of known impurity (1